LONDON and NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced financial and operational results for the second quarter ended June 30, 2026, and provided a corporate update.
“During the second quarter of 2026, we made tremendous progress towards transforming MeiraGTx into a commercial company,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “We acquired bota-vec from J&J and started working on the global filings for this product and establishing the market access and commercial infrastructure ahead of the potential first commercial launch in 2027. In addition, we made meaningful progress with our wholly owned AAV2-hAQP1 program for a significant unmet need, radiation induced xerostomia (RIX). We were awarded Breakthrough Therapy Designation in March 2026 based on very strong 3-year data from our Phase 1 AQUAx clinical study (n=24), indicating strong durable responses in late-stage RIX patients. We completed enrollment in our pivotal Phase 2 AQUAx2 clinical study of AAV2-hAQP1 in RIX in the second quarter and are now working expeditiously to submit regulatory filings for bota-vec this year and preparing for AAV2-hAQP1 filings mid next year.”
Dr. Forbes continued, “We are engaging high quality market access and commercial teams as we build our internal infrastructure to expedite potential launches of these first in class disease modifying therapies. We are particularly excited to be joined by two senior leaders previously with J&J, Penny Fleck as our Chief Development Officer, who has two decades of experience leading research and development at Takeda Pharmaceuticals, Johnson & Johnson Innovative Medicine, and ONL Therapeutics, including running the bota-vec program at J&J, and more recently, John Knighton as Executive Vice President of Global Manufacturing and Supply Chain. John has over 30 years of experience in biologic manufacturing and previously served as the Head of Cell & Gene Therapy API at Janssen Pharmaceuticals, Inc., supporting the successful launch of CARVYKTI®. Together, Penny and John provide extensive experience and expertise in achieving marketing approvals and successful commercial launches of many pharmaceutical products, and will be instrumental as we transition the Company into one that is well prepared for the potential launches of two products over the next two years.”
Dr. Forbes added, “We also remain very excited about our Riboswitch platform. Following discussion with the FDA, we are finalizing the requirements for clinical development and progressing to first in human studies with our Ribo-Leptin program. We anticipate following this first clinical study of the Riboswitch technology with a second program in neuropathic pain which is supported by very strong animal data. In each case, a precise dose of the therapeutic gene product is produced in vivo based on an oral small molecule daily pill. We are eager to progress this powerful novel technology through clinical development to address conditions that cannot be readily addressed using any of the current therapeutic modalities available.”
*Janssen Pharmaceuticals, Inc., a Johnson & Johnson company
Second Quarter 2026 Highlights
Botaretigene Sparoparvovec (bota-vec) for the Treatment of X-Linked Retinitis Pigmentosa (XLRP):
AAV2-hAQP1 for the Treatment of Radiation-Induced Xerostomia:
Up to $400 Million Strategic Investment from Oberland Capital:
AAV-GAD for the Treatment of Parkinson’s Disease:
AAV-AIPL1 for LCA4:
Riboswitch Gene Regulation Technology Platform for in vivo Delivery:
Corporate and Leadership Updates
As of June 30, 2026, MeiraGTx had cash and cash equivalents of approximately $143.2 million as well as $5.6 million in accounts receivables, $24.4 million in unbilled receivables and $14.3 million in tax incentive receivables. Together with the second purchase of $25.0 million of royalty notes and $10.0 million proceeds from the sale of the Company’s ordinary shares under the agreements with Oberland Capital in July 2026, and the additional $95.0 million upfront payment due from Hologen and associated reimbursements, the Company believes that it will have sufficient capital to fund operating expenses and capital expenditure requirements into the second half of 2028. This estimate does not include the $135.0 million in potential near-term cash consideration from Lilly upon achievement of certain development and regulatory approval milestones, or any subsequent tranches available under the royalty note purchase agreement with Oberland Capital.
Financial Results
Cash, cash equivalents and restricted cash were $145.4 million as of June 30, 2026, compared to $34.4 million as of June 30, 2025.
Service revenue was $11.9 million for the three months ended June 30, 2026, compared to nil for the three months ended June 30, 2025. The increase of $11.9 million was due to revenue recognized for the contract manufacturing services provided to Lilly under the Lilly collaboration agreement and related agreements.
Service revenue – related party was $104.9 million for the three months ended June 30, 2026, compared to $3.7 million for the three months ended June 30, 2025. The increase of $101.2 million was due to the release of deferred revenue from the termination of the original asset purchase agreement and supply agreement with J&J and the development and transition services provided to Reogen Limited (Reogen), formerly known as Hologen Neuro AI Limited, under the Hologen collaboration agreement and related agreements, which was partially offset by decreased activity of PPQ services under the original asset purchase agreement and related agreements with J&J as the work was substantially completed in the first half of 2025.
License revenue – related party was $204.6 million for the three months ended June 30, 2026, compared to nil for the three months ended June 30, 2025. The increase of $204.6 million was due to revenue recognized for the licenses granted to Reogen for the AAV-GAD and AAV-BDNF programs and the AAV-GAD delivery device.
Cost of service revenue was $1.4 million for the three months ended June 30, 2026 compared to nil for the three months ended June 30, 2025. The increase of $1.4 million was due to costs incurred during the three months ended June 30, 2026 in connection with contract manufacturing services provided to Lilly under the Lilly collaboration agreement and related agreements.
Cost of service revenue – related party was $5.8 million for the three months ended June 30, 2026 compared to $2.7 million for the three months ended June 30, 2025. The increase of $3.1 million was due to costs incurred during the period related to the development and transition services provided to Reogen under the Hologen collaboration agreement and related agreements, partially offset by the decreased activity of PPQ services due to the termination of the original asset purchase agreement and related agreements with J&J during the second quarter of 2026.
General and administrative expenses were $12.0 million for the three months ended June 30, 2026, compared to $12.3 million for the three months ended June 30, 2025. The decrease of $0.3 million was primarily due to decreases in legal fees and share-based compensation expense due to vesting in prior periods. These decreases were partially offset by increases in business development expenses and personnel costs.
Research and development expenses were $57.8 million for the three months ended June 30, 2026, compared to $33.5 million for the three months ended June 30, 2025. The increase of $24.3 million was primarily due to the reacquisition of bota-vec from J&J under the asset purchase agreement. Costs related to the AAV2-hAQP1 clinical program increased due to the manufacturing of clinical trial batch material during the three months ended June 30, 2026 and higher clinical trial related spend. In addition, other research and development expenses increased due to employee and employee-related costs, facilities costs and other general research and development costs. These increases were partially offset by decreases in the Company’s AAV-GAD program due to a higher cost of clinical trial material batches being manufactured during the three months ended June 30, 2025. Manufacturing costs decreased due to higher manufacturing batch costs being allocated to the clinical programs during the three months ended June 30, 2026 and costs associated with the Company’s preclinical programs decreased primarily related to the gene regulation program due to the completion of certain preclinical studies in 2025.
Foreign currency loss was $1.5 million for the three months ended June 30, 2026 compared to a gain of $8.6 million for the three months ended June 30, 2025. The change of $10.1 million was primarily due to the weakening of the U.S. dollar against the pound sterling and euro as it relates to the valuation of the Company’s intercompany payables and receivables.
Interest income was $0.7 million for the three months ended June 30, 2026 compared to $0.4 million for the three months ended June 30, 2025. The increase of $0.3 million was due to higher cash balances in interest bearing accounts during 2026 offset by lower interest rates.
Interest expense was $3.5 million for the three months ended June 30, 2026 compared to $3.0 million for the three months ended June 30, 2025. The increase of $0.5 million was primarily due to the transaction cost related to the issuance of the royalty note under the agreement with Oberland Capital, which is measured at fair value, and the write-off of unamortized deferred financing cost due to the termination of the Notes Purchase Agreement with Perceptive Credit Holdings III, LP, which is offset by a lower interest rate.
Loss on derivative liability was $5.2 million for the three months ended June 30, 2026 compared to nil for the three months ended June 30, 2025. The increase of $5.2 million was due to the initial measurement of the derivative liability associated with the right granted under the securities purchase agreement with Oberland Capital.
Loss on equity method investee was $71.9 million for the three months ended June 30, 2026, compared to nil for the three months ended June 30, 2025. The loss primarily reflects the Company’s proportionate share of Reogen’s expenses associated with the acquired in-process research and development assets relating to the AAV-GAD and AAV-BDNF programs and the AAV-GAD delivery device, as well as Reogen’s ongoing research and development activities.
Income tax expense was $2.4 million for the three months ended June 30, 2026 compared to nil for the three months ended June 30, 2025. The increase of $2.4 million was primarily driven by taxable income generated from strategic collaboration and other non-recurring transactions, partially offset by valuation allowances and losses in jurisdictions where no tax benefit was recognized.
Net income attributable to ordinary shareholders for the quarter ended June 30, 2026 was $160.7 million, or $1.76 basic and $1.71 diluted net income per ordinary share, compared to a net loss attributable to ordinary shareholders of $38.8 million, or $0.48 basic and diluted net loss per ordinary share for the quarter ended June 30, 2025.
For more information related to our clinical trials, please visit www.clinicaltrials.gov
About MeiraGTx
MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical-stage genetic medicines company with a broad pipeline with four late-stage clinical programs. Each of these programs use local delivery of small doses resulting in disease modifying effects in both inherited and more common diseases, in the eye, radiation-induced xerostomia, and Parkinson’s disease. MeiraGTx uses its innovative technology in optimization of capsids, promoters and novel translational control elements to develop best in class, potent, safe viral vectors. MeiraGTx’s broad pipeline is supported by end-to-end in-house manufacturing. MeiraGTx has built the most comprehensive manufacturing capabilities in the industry, including two that are licensed for GMP viral vector production and a GMP QC facility with clinical and commercial licensure. In addition, MeiraGTx has developed a proprietary manufacturing platform process over 10 years based on more than 20 different viral vectors with leading yield and quality aspects and commercial readiness. Uniquely, MeiraGTx has developed a novel technology for in vivo delivery of any biologic therapeutic using oral small molecules. This transformative riboswitch gene regulation technology allows precise, dose-responsive control of gene expression by oral small molecules. MeiraGTx is focusing the riboswitch platform on the regulated in vivo delivery of metabolic peptides, including GLP-1, GIP, Glucagon, Amylin, PYY and Leptin, as well as cell therapy, CAR-T for liquid and solid tumors and autoimmune diseases, and additionally PNS targets addressing long term intractable pain. MeiraGTx has developed the technology to apply genetic medicine to common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains high.
For more information, please visit www.meiragtx.com
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and anticipated milestones regarding our pre-clinical and clinical data, reporting of such data and the timing of results of data and regulatory matters, statements regarding our collaborations and statements regarding our future obligations under the agreement with Oberland Capital, as well as statements that include the words “expect,” “will,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “could,” “should,” “would,” “continue,” “anticipate,” “eligible” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic transactions or priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug or rare pediatric disease designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of pandemics, epidemics or outbreaks of infectious diseases on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Contacts
Investors:
MeiraGTx
Investors@meiragtx.com
or
Media:
Jordyn Temperato
LifeSci Communications
jtemperato@lifescicomms.com
| MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (unaudited) (in thousands, except share and per share amounts) | ||||||||||||||||
| For the Three-Month Periods Ended June 30, | For the Six-Month Periods Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenues: | ||||||||||||||||
| Service revenue | $ | 11,885 | $ | — | $ | 11,885 | $ | — | ||||||||
| Service revenue - related party | 104,906 | 3,691 | 105,199 | 5,617 | ||||||||||||
| License revenue - related party | 204,643 | — | 204,643 | — | ||||||||||||
| Total revenue | 321,434 | 3,691 | 321,727 | 5,617 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of service revenue | 1,401 | — | 1,401 | — | ||||||||||||
| Cost of service revenue - related party | 5,763 | 2,676 | 5,961 | 4,054 | ||||||||||||
| General and administrative | 12,013 | 12,313 | 20,941 | 21,677 | ||||||||||||
| Research and development | 57,832 | 33,495 | 89,816 | 66,275 | ||||||||||||
| Total operating expenses | 77,009 | 48,484 | 118,119 | 92,006 | ||||||||||||
| Income (loss) from operations | 244,425 | (44,793 | ) | 203,608 | (86,389 | ) | ||||||||||
| Other non-operating income (expense): | ||||||||||||||||
| Foreign currency (loss) gain | (1,466 | ) | 8,624 | (4,303 | ) | 12,311 | ||||||||||
| Interest income | 706 | 408 | 895 | 1,379 | ||||||||||||
| Interest expense | (3,509 | ) | (3,034 | ) | (6,357 | ) | (6,077 | ) | ||||||||
| Loss on derivative liability | (5,223 | ) | — | (5,223 | ) | — | ||||||||||
| Loss on equity method investee | (71,902 | ) | — | (71,902 | ) | — | ||||||||||
| Income tax expense | (2,362 | ) | — | (2,362 | ) | — | ||||||||||
| Net income (loss) | $ | 160,669 | $ | (38,795 | ) | $ | 114,356 | $ | (78,776 | ) | ||||||
| Net income (loss) attributed to: | ||||||||||||||||
| Net income (loss) attributed to shareholders | 160,720 | (38,795 | ) | 114,407 | (78,776 | ) | ||||||||||
| Net loss attributed to non-controlling interest | (51 | ) | — | (51 | ) | — | ||||||||||
| Net income (loss) | $ | 160,669 | $ | (38,795 | ) | $ | 114,356 | $ | (78,776 | ) | ||||||
| Other comprehensive gain (loss): | ||||||||||||||||
| Foreign currency translation gain (loss) attributed to shareholders | 677 | (2,459 | ) | 849 | (3,806 | ) | ||||||||||
| Foreign currency translation loss attributed to non-controlling interest | (4 | ) | — | (4 | ) | — | ||||||||||
| Comprehensive income (loss) | $ | 161,342 | $ | (41,254 | ) | $ | 115,201 | $ | (82,582 | ) | ||||||
| Net income (loss) per ordinary share: | ||||||||||||||||
| Basic | $ | 1.76 | $ | (0.48 | ) | $ | 1.32 | $ | (0.99 | ) | ||||||
| Diluted | $ | 1.71 | $ | (0.48 | ) | $ | 1.30 | $ | (0.99 | ) | ||||||
| Weighted-average number of ordinary shares outstanding: | ||||||||||||||||
| Basic | 91,418,527 | 80,585,625 | 86,387,685 | 79,813,273 | ||||||||||||
| Diluted | 93,805,296 | 80,585,625 | 88,115,023 | 79,813,273 | ||||||||||||
| MEIRAGTX HOLDINGS PLC AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands, except share and per share amounts) | ||||||||
| June 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 143,166 | $ | 65,931 | ||||
| Accounts receivable | 3,176 | — | ||||||
| Accounts receivable - related party | 2,438 | 3,000 | ||||||
| Unbilled receivables - related party | 24,364 | — | ||||||
| Prepaid expenses | 3,989 | 6,017 | ||||||
| Tax incentive receivable | 14,286 | 15,286 | ||||||
| Other current assets | 26,928 | 1,527 | ||||||
| Total Current Assets | 218,347 | 91,761 | ||||||
| Property, plant and equipment, net | 100,333 | 105,465 | ||||||
| Intangible assets, net | 421 | 578 | ||||||
| Restricted cash | 2,200 | 2,262 | ||||||
| Other assets | 1,362 | 1,147 | ||||||
| Equity method and other investments | 39,838 | 6,749 | ||||||
| Right-of-use assets - operating leases, net | 11,524 | 12,852 | ||||||
| Right-of-use assets - finance leases, net | 22,424 | 23,616 | ||||||
| TOTAL ASSETS | $ | 396,449 | $ | 244,430 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 11,668 | $ | 10,066 | ||||
| Accrued expenses | 21,225 | 32,893 | ||||||
| Lease obligations - operating leases, current | 2,260 | 2,851 | ||||||
| Lease obligations - finance leases, current | 40 | 38 | ||||||
| Deferred revenue, current | 359 | — | ||||||
| Deferred revenue - related party, current | 5,076 | 1,776 | ||||||
| Note payable, net, current | — | 24,648 | ||||||
| Corporate tax liability | 2,362 | — | ||||||
| Other current liabilities | 15,106 | 50,283 | ||||||
| Total Current Liabilities | 58,096 | 122,555 | ||||||
| Deferred revenue - related party | 11,101 | 65,120 | ||||||
| Lease obligations - operating leases | 9,936 | 11,351 | ||||||
| Lease obligations - finance leases | 85 | 109 | ||||||
| Asset retirement obligations | 1,450 | 1,399 | ||||||
| Note payable, net | 100,000 | 49,689 | ||||||
| TOTAL LIABILITIES | 180,668 | 250,223 | ||||||
| COMMITMENTS AND CONTINGENCIES (Note 13) | ||||||||
| SHAREHOLDERS' EQUITY (DEFICIT): | ||||||||
| Ordinary Shares, $0.00003881 par value, 1,288,327,750 authorized, 94,188,118 and 81,120,931 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively | 3 | 3 | ||||||
| Capital in excess of par value | 932,323 | 808,021 | ||||||
| Treasury shares | (18,193 | ) | — | |||||
| Accumulated other comprehensive gain | 3,255 | 2,406 | ||||||
| Accumulated deficit | (701,816 | ) | (816,223 | ) | ||||
| Non-controlling interest | 209 | — | ||||||
| Total Shareholders' Equity (Deficit) | 215,781 | (5,793 | ) | |||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | $ | 396,449 | $ | 244,430 | ||||